QA Specialist

Summary

The QA Specialist reporting to Senior Director, QA will support manufacturing operations from clinical to commercial day to day, reviewing batch records, review documents for manufacturing teams to resolve issues and ultimately review and release batches. This person will have a high level of organization skills and be a critical thinker possessing a willing and able to pitch in where needed perspective and approach.

Principal Duties/Responsibilities

• Quality supporting manufacturing operations - Clinical to start and in the future commercial - day to day, continuing review of batch records, reviewing documents for manufacturing teams to resolve any quality issues and ultimately review and release batches
• Assist in implementing and maintaining the quality systems programs including but not limited to:
• Deviation management
• Change control
• Corrective and preventative action
• Material controls/material management
• Conduct batch record review for clinical and commercial product manufacturing
• Maintain approved labeling materials and process/distribute per company procedures
• Under limited direction and supervision, create, review, and revise standard operating procedures
• Support and contribute to quality improvement initiatives
• Participate in team meetings and make recommendations related to changes in processes, process improvements and provide suggestions as needed
• Assist in the internal audits as required
• Other duties, as assigned
  
  

Qualifications

• Bachelor's degree, required
• Minimum 3-5 years of relevant pharmaceutical, biotechnology or medical device industry experience
• Background in one or more specialties of biotechnology: bioprocess, cell technology, biomedical engineering, cell therapy, tissue engineering, regenerative medicine, process development, cell biology, chemical engineering, and/or biochemical engineering
• Experience executing validations plans and reviewing validation protocols, reports and technical documents.
• Process Excellence training, preferred
• ASQ certification, preferred
• Familiarity with inspection methods and techniques, preferred
• Knowledge and experience with standard bioprocessing skills as well as use and maintenance of common laboratory procedures and equipment, preferred
• May be required to work evenings, off-hours, holidays or extended periods of time
• Will spend a portion of time in clean room environment to provide oversight to manufacturing operations and will be required to meet applicable gowning and personal protective equipment guidelines
  
  

Work Environment

The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.